Spectranetics Announces FDA Clearance of Peripheral Laser Atherectomy Devices for In-Stent Restenosis

July 23, 2014—Spectranetics Corporation announced that it has received US Food and Drug Administration (FDA) clearance of its Turbo-Tandem and Turbo Elite peripheral atherectomy products for the treatment of in-stent restenosis (ISR).

FDA clearance comes after the clinical findings of the Excimer Laser Randomized Controlled Study for Treatment of Femoropopliteal In-Stent Restenosis (EXCITE ISR) trial, the first multicenter, randomized prospective trial conducted for the treatment of ISR. In this study, laser atherectomy with adjunctive percutaneous transluminal angioplasty (PTA) demonstrated superior safety and efficacy, showing a 94% procedural success rate compared to 83% with PTA alone. Complete results from the EXCITE trial have been submitted to a peer-reviewed medical journal.

The average lesion length was approximately 20 cm as compared to various stent IDE studies with average lesion lengths of 4 to 6 cm; a high number of complex or advanced disease-state patients were enrolled in the trial, indicative of success in treating all types of ISR lesions, including complex cases.

“With mean lesion length at 20 cm, approximately one-third of the patients being retreated for ISR, and also approximately one-third with total occlusions, EXCITE represents a very sick, real-world patient set,” said Eric Dippel, MD, of Genesis Heart Institute in Davenport, Iowa, in the company's press release. “The highly superior outcomes for both safety and efficacy and the delta in procedural success rates between the two arms of the trial are compelling. Given that a significant number of patients today are treated with PTA alone with very poor outcomes, EXCITE demonstrates a proven treatment algorithm that physicians and their patients need.”

The EXCITE ISR trial was initially designed to enroll a maximum of 318 subjects at up to 35 sites, randomized 2:1 treatment to control. Earlier this year, Spectranetics announced early success of the trial based on achieving highly significant statistical superiority in both safety and efficacy among 250 patients. The treatment arm is laser atherectomy combined with PTA, and the control arm is PTA alone. The primary efficacy endpoint is freedom from target lesion revascularization through 6 months. The primary safety endpoint is freedom from major adverse events (all-cause mortality, major amputation in the target limb, or target lesion revascularization) at 30 days.